We offer integrated solutions concerning regulatory approval,
clinical research, reimbursement approval, market research, distribution and logistics.
A clinical trial of medical devices refers to the process in which the medical institutions qualified from conducting clinical trial of medical devices testing and verifying the safety and efficacy of the medical devices submitted to register in normal condition.
As the first medical device CRO in Korea, Synex could be a reliable partner for manufacturers who are unfamiliar with medical device clinical trials to successfully complete them.
A lot of experience in medical device clinical research
Fast Study Approval
Strict Compliance to GCP
Connected to Regulatory Affairs, nHTA and Reimbursement
In order for medical devices to enter the market, safety and effectiveness must be evaluated according to the relevant regulations. Medical devices R&D product approval varies greatly in terms of period and cost depending on the strategy, so it is necessary to check the class and classification, intended use and status of the medical device.
Synex provides regulatory services with clear understanding on Ministry of Food and Drug Safety approval standards and efficient communication with agencies based on professional knowledge and experience. Also, we can provide global regulatory affairs with clear understanding on approval standards, requirements and regulations of target countries and efficient communication with local agencies and representatives.
Provide information of domestic/ international regulations
Set approval goals that abides by the business goal
Provide credible information
Reimbursement process in parallel
Link with global approval and quality system
Fast problem solving
Communication over clients’ benefit
Good Manufacturing Practice (GMP) stands for a quality management system which provides the matters to be observed in order to guarantee the quality of medical devices throughout the entire process including development , purchasing, manufacturing, inspection, packing, installation, storage, shipment, claim and return so that high quality products can be supplied consistently at all times.
Synex provides a strategic plan to establish a quality system within the shortest time period cost-effectively based on the understanding of the specialized customer requirements.
Apply accurate MFDS regulations according to the size of manufacturer
Minimize costs by quality systems optimization
Customer-centered quality systems training
Synex provides professional consultation service with more than 20 years of experience. We minimize conflicts between customers, hospitals and HIRA (Health Insurance Review & Assessment) through effective communication based on objective evidences.
Latest information on policy changes-
Business plan based on reimbursement strategies
New Health Technology Assessment (nHTA)
Professional communication to the best interest of customer
Our internal and external expertise in multiple disciplines design and offer goal-oriented research method for clients interested in Korean healthcare market.
The internal data of market, such as analysis of competitiveness among products, sales performance or success/failure of products, etc. are gathered through in-depth interviews with professionals such as clinical doctors, medical institutions, business experts and regulatory agencies. Finally, experts of Synex put data together and analyze information properly for the customer’s purpose.
Distribution partnership options
Quantitative research based on national NIH claim data
Qualitative research through wide access to KOLs
Reality checks with Korean business experts
Advices on market access strategies
Under In-Country Caretaker service, Synex acts as your total business representative in Korea. Through the ICC Service model, the foreign manufacturers are able to set up a legal entity that has similar characteristics as branch without much initial investment while the distributor is able to concentrate on sales and customers by escaping from the duties such as strict product registration & license management or reimbursement, etc. to lead an even more effective business structure.
Faster Market Access
Multiple Distribution Partnerships
Perfect Replacement of Your Subsidiary in Korea